Laparoscopic Adjustable Gastric Banding Versus Laparoscopic Sleeve Gastrectomy

• Sponsor: North Texas Veterans Healthcare System (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00434655
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

• The investigators aim to determine the clinical and metabolic outcomes of two available bariatric restrictive procedures: laparoscopic adjustable gastric banding (LAP-BAND) and laparoscopic sleeve gastrectomy for the treatment of morbid obesity (BMI > 35 with comorbidities or BMI > 40) in VETERANS.

• The investigators hypothesize that the short and long term outcomes between laparoscopic adjustable gastric banding (LAP-BAND) and sleeve gastrectomy are similar in VETERANS.

Condition or Disease	Intervention/Treatment	Phase
Morbid Obesity	Procedure: Laparoscopic restrictive procedure	Phase 3

Detailed Description

This is a bariatric surgery Phase 3 prospective trial.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Laparoscopic Adjustable Gastric Banding Versus Laparoscopic Sleeve Gastrectomy: A Prospective Trial
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 LAP BAND	Procedure: Laparoscopic restrictive procedure; Morbidly Obese VETERANS will receive one of two laparoscopic bariatric restrictive procedures.
Experimental: 2 Sleeve gastrectomy	Procedure: Laparoscopic restrictive procedure; Morbidly Obese VETERANS will receive one of two laparoscopic bariatric restrictive procedures.

Outcome Measures

Primary Outcome Measures

1. Short and long term clinical outcomes [5 years]

Secondary Outcome Measures

1. Metabolic outcomes [5 years]

2. Esophago-gastric physiology [2 years]

3. Hormonal physiology [5 years]

4. Procedure costs [5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Morbidly obese VETERANS ONLY (BMI>35 with comorbidities or BMI > 40)

• Age > 18 y/o

Exclusion Criteria:

• Pregnancy

• Severe uncontrolled medical or psychiatric conditions

• Previous bariatric surgery

• Multiple previous abdominal surgeries

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA North Texas	Dallas	Texas	United States	75216

Sponsors and Collaborators

• North Texas Veterans Healthcare System

Investigators

• Principal Investigator: Esteban Varela, MD, VA North Texas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00434655
• Other Study ID Numbers: 07-010
• First Posted: Feb 13, 2007
• Last Update Posted: Dec 15, 2009
• Last Verified: Dec 1, 2009

• Keywords provided by , ,: Morbid obesity; Bariatric surgery; Obesity surgery; Gastric banding; Sleeve gastrectomy
• Additional relevant MeSH terms: Obesity; Obesity, Morbid

Study Results

No Results Posted as of Dec 15, 2009